BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1932531 · Received December 18, 2010

    Report

    Report Number
    2050012-2010-01608
    Event Type
    Malfunction
    Date Received
    December 18, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEONATAL SAMPLES WERE COLLECTED IN "BABY BULLETS" SAMPLE CONTAINERS. THE INSTRUMENT CALIBRATION AND QC RESULTS WERE ACCEPTABLE PRIOR TO AND AFTER THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED A PRECISION TEST AND OBTAINED 9.6% CV FOR BUN AND 2.1% CV FOR CR-S. THE FSE REPLACED THE SAMPLE PROBE AND PERFORMED A PRECISION TEST AGAIN, WHICH PRODUCED IMPROVED PRECISIONS OF 1.5% CV FOR BUN AND 0.8% CV FOR CR-S.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY HIGH CREATININE (CR-S) RESULT GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY, AND QUESTIONED BY THE MEDICAL STAFF BECAUSE THE RESULT DID NOT CORRELATE WITH THE UREA NITROGEN (BUN) RESULT. SUBSEQUENT TESTING ON THE SAME AND ON A REDRAW SAMPLE PRODUCED LOWER RESULTS. PATIENT TREATMENT WAS NOT CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1